BG9928 in Subjects With Hepatic Impairment

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00858156
First received: March 5, 2009
Last updated: January 26, 2010
Last verified: January 2010
  Purpose

The primary objective of the study is to evaluate the effect of hepatic function on the pharmacokinetics of a single oral dose of BG9928 in subjects with mild and moderate hepatic impairment and in subjects with normal hepatic function.


Condition Intervention Phase
Hepatic Impairment
Drug: BG9928
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: An Open-Label, Single-Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Oral BG9928 in Subjects With Mild and Moderate Hepatic Impairment and in Healthy Subjects

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • The comparative effect of hepatic function on the pharmacokinetics of a single oral dose of BG9928 in subjects with mild and moderate hepatic impairment as compared to subjects with normal hepatic function [ Time Frame: 1 week post dose ] [ Designated as safety issue: Yes ]

Enrollment: 23
Study Start Date: April 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: BG9928
    Oral 75 mg single dose
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must be between the ages of 18 and 75, inclusive.
  • Must have a Body Mass Index (BMI) between 19 kg/m2 and 36 kg/m2, inclusive.

The following criteria apply only to subjects enrolled into Groups 1 and 2 (mild or moderate hepatic impairment):

  • Must have stable hepatic disease (i.e., no change in disease status within the last 2 months as determined by the enrolling Investigator) with laboratory and clinical findings that support the diagnosis of hepatic impairment.
  • Must have a total Child-Pugh score (Section 22, Appendix I) of 5-6 (mild), or 7-9 (moderate).
  • Must be otherwise healthy as determined by the Investigator on the basis of pre-study physical examination, medical history, 12-lead ECG, vital signs, and clinical laboratory parameters. Subjects with controlled hypertension and those problems directly associated with the primary diagnosis of hepatic impairment may be included. Subjects with stable, mild, chronic concurrent diseases, such as degenerative joint disease, may be included.

Exclusion Criteria:

  • History of an allergic reaction to any methylxanthine-containing compound.
  • History of seizure within the past 10 years, or use of any medication for the suppression of seizures within the past 5 years.
  • History of brain surgery, meningitis/encephalitis, penetrating head trauma, stroke, or transient ischemic attack within the past 6 months.
  • History of active (within 6 months) drug or alcohol abuse, a positive drug screen (without a medically indicated rationale), or a positive alcohol breath test at Screening or on Day -2.
  • History of Human Immunodeficiency Virus (HIV) antibody.
  • Serious systemic infection (e.g., septicemia) within the 30 days prior to Day 1.
  • Fever, with body temperature >38oC, within the 48 hours prior to Day 1.
  • Active bacterial or viral infection.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00858156

Locations
United States, Florida
Miami, Florida, United States, 33014
Orlando, Florida, United States, 32809
Sponsors and Collaborators
Biogen Idec
Investigators
Study Director: Biogen Idec Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec, Medical Director, Biogen Idec, Inc
ClinicalTrials.gov Identifier: NCT00858156     History of Changes
Other Study ID Numbers: 161HI101
Study First Received: March 5, 2009
Last Updated: January 26, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen Idec:
Pharmacokinetics

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 23, 2014